<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20211016052783N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-27</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Muscle Energy Technique on Trismus after third molar surgery</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Muscle Energy Technique on Temporomandibular Joint Motion in People with Trismus of Chewing Muscles due to Third Molar Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59471</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we use the randomized permutation block method for random assignment. The procedure will be as follows: quadruple blocks with a combination of A and B ( group A intervention and group B control ) will be the criteria for action. Given that in quadruple blocks, six different combinations of blocks can exist, a number is assigned to each block (from 1 to 6). The number of blocks is as follows:
Block 1: AABB
Block 2: BBAA
Block 3: ABBA
Block 4: BAAB
Block 5: ABAB
Block 6: BABA
Using a table of random numbers, considering the numbers 1 to 6 and deleting the numbers 0, 7, 8 and 9, respectively, the blocks are selected and the way of allocating patients for each of the groups A and B is done according to the selected blocks. Obviously, the list obtained from this method of allocation will be completely random and balanced. After preparing a randomization list for each patient, they will have a number in order of enrollment (from 1 to 48). A sealed envelope is prepared with A or B written inside the envelope based on the compiled list. The researcher, who is not aware of the main list, after registering the patient who entered the study and checking the person's number, takes the relevant envelope and opens it in the patient's bedside and realizes the type of intervention based on the contents of the envelope. In this way, the researcher is not aware of the list and only after the patient entered into the study and finding out if he/she is qualified, he/she realizes the type of intervention by opening the envelope.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Trismus following Third Molar Surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Muscle energy technique, In a seated position the subject is asked to open the mouth to its comfortable limit, the operator then placed one hand around the subject's jaw, while the other hand grasped the head for stability, the subject is then asked to attempt open the mouth for 10 seconds against the resistance applied by the operator's hand placed below the jaw, this reciprocal inhibition procedure is repeated five times, After each time, the jaw is moved to a new barrier before repeating the technique. this technique is performed from the first day after surgery daily for seven days. Intervention 2: Control group: They do not receive any intervention.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Noormohammadi ghomi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 4, Ayati Alley, 32nd Square, East Janbazan St., Narmak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1649973971</zip>
        <telephone>+98 21 7794 8173</telephone>
        <email>snmohamadi@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Cyrus Taghizadeh Delkhosh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Headquarters of Semnan University of Medical Sciences and Health Services, Basij Blvd</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514799442</zip>
        <telephone>+98 23 3332 8502</telephone>
        <email>cyrustaghizadeh@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with an inability to open their mouth after third molar surgery that has less than 40 mm interincisal distance
People who have had 24 hours of third molar surgery
People with pain and spasm in the masticatory muscles after third molar surgery
Surgery of all patients is performed by a same surgeon and a same assistant surgeon in the same conditions and under local anesthesia</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Degenerative Temporomandibular joint arthritis
Inflammatory Temporomandibular joint arthritis
Infective Temporomandibular joint arthritis
Malignant tumors of the face and jaw
History of dislocation of Temporomandibular joint
History of fracture of Temporomandibular joint
History of previous surgery of jaw or Temporomandibular joint
Hypermobile Temporomandibular joint</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R25.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cramp and spasm</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Muscle energy technique, In a seated position the subject is asked to open the mouth to its comfortable limit, the operator then placed one hand around the subject's jaw, while the other hand grasped the head for stability, the subject is then asked to attempt open the mouth for 10 seconds against the resistance applied by the operator's hand placed below the jaw, this reciprocal inhibition procedure is repeated five times, After each time, the jaw is moved to a new barrier before repeating the technique. this technique is performed from the first day after surgery daily for seven days.</i_keyword>
      <i_keyword>Control group: They do not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The degree of displacement of the Temporomandibular Joint Condyle on the X-axis. Timepoint: On the first day after surgery before and after the intervention and then on the 7th day after surgery (end of the intervention period). Method of measurement: By Sonography and MATLAB program.</prim_outcome>
      <prim_outcome>The degree of displacement of the Temporomandibular Joint Condyle on the Y-axis. Timepoint: On the first day after surgery before and after the intervention and then on the 7th day after surgery (end of the intervention period). Method of measurement: By Sonography and MATLAB program.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maximum mouth opening. Timepoint: On the first day after surgery before and after the intervention and then on the 7th day after surgery (end of the intervention period). Method of measurement: Use caliper that is calibrated in millimeter.</sec_outcome>
      <sec_outcome>Intensity of pain. Timepoint: On the first day after surgery before and after the intervention and then on the 7th day after surgery (end of the intervention period). Method of measurement: Use Visual Analogue Scale.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-31</approval_date>
        <contact_name>Ethics committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Headquarters of Semnan University of Medical Sciences and Health Services, Basij Blvd Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
